- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01087827
Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures
November 6, 2012 updated by: Christiana Care Health Services
Anatomical Determinants of Forearm and Upper Arm Oscillometric Blood Pressure Differences
The first purpose of this study is to see how blood pressures taken at different sites, specifically the forearm, upper arm and heart vessels, are different.
The second purpose is to see if body structures such as vessel size and depth, size of the arm, and amount of tissue in the arm influence differences in blood pressures taken at these sites.
The third purpose is to develop a mathematical model of the waves generated by the arm arteries (brachial and radial) to predict differences in forearm and upper arm blood pressures.
The results of the study may be used to design more accurate non-invasive blood pressure monitors for the forearm site.
Study Overview
Status
Completed
Conditions
Detailed Description
Accurate blood pressure (BP) measurement is required to provide appropriate healthcare.
Inaccurate BPs may lead to under and/or over-treatment of health conditions and medical diseases such as hypertension.
Blood pressure (BP) measurement using automatic, non-invasive oscillometric monitors is common in clinics, physicians'offices and hospital settings.
The brachial (upper arm) site is the gold standard for non-invasive BPs.
However, in some situations, this site is inaccessible due to injury, surgery, dialysis shunts, intravenous devices, and lymphedema.
When the upper arm is difficult to access or the available BP cuffs do not fit an individual's arm, the forearm site is often the preferable alternative.
The increased incidence of obesity nationally also contributes to the heightened use of forearm BPs.
Questions remain concerning the accuracy of forearm non-invasive BP measurements.
Although most researchers report that upper arm and forearm readings are not interchangeable, size of differences vary for individuals and factors influencing differences in readings have not been thoroughly investigated.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 10718
- Christiana Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing non-emergent cardiac catheterization
Description
Inclusion Criteria:
- 18 years of age
- able to speak and write in English
Exclusion Criteria:
- Individuals with non-intact skin where the BP cuffs would be placed
- Individuals with injury or surgery to the arm within the last month
- Individuals with lymphedema in the limb selected for measurements
- Individuals with arteriovenous fistulas
- Individuals with differences > 5 mm Hg between right and left arm oscillometric systolic BP measurements
- Individuals with documented valvular disease
- Individuals with atrial fibrillation or atrial flutter (as recommended by BP device manufacturers due to device inaccuracy)
- Individuals with an International Normalized Ratio (INR) > 1.7
- Individuals with intravenous catheters in both arms
- Individuals who require immediate cardiac surgery or unanticipated emergency treatment or who are unstable during the procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anatomical determinants of forearm and upper arm blood pressure differences
Time Frame: 6 months
|
body mass index, upper arm circumference, biceps skin-fold measurement, forearm and upper arm vessel diameter, forearm and upper arm vessel depth
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood pressure differences; quantitative model of waveform propagation and reflection able to predict differences between upper arm and forearm blood pressures
Time Frame: 6 months
|
blood pressure at forearm, upper arm, aortic root radial artery tonometry to determine radial artery waveform and pressure measurements non-invasively |
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen A Schell, PhD, University of Delaware
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schell K, Lyons D, Bradley E, Bucher L, Seckel M, Wakai S, Carson E, Waterhouse J, Chichester M, Bartell D, Foraker T, Simpson EK. Clinical comparison of automatic, noninvasive measurements of blood pressure in the forearm and upper arm with the patient supine or with the head of the bed raised 45 degrees: a follow-up study. Am J Crit Care. 2006 Mar;15(2):196-205.
- Schell K, Bradley E, Bucher L, Seckel M, Lyons D, Wakai S, Bartell D, Carson E, Chichester M, Foraker T, Simpson K. Clinical comparison of automatic, noninvasive measurements of blood pressure in the forearm and upper arm. Am J Crit Care. 2005 May;14(3):232-41.
- Schell K, Morse K, Waterhouse JK. Forearm and upper-arm oscillometric blood pressure comparison in acutely ill adults. West J Nurs Res. 2010 Apr;32(3):322-40. doi: 10.1177/0193945909351887.
- Schell K, Waterhouse,JK. Comparison of forearm and upper arm automatic noninvasive blood pressures in college students. Internet Journal of Advanced Nursing Practice 2007, 9 (1): 10 pages
- Schell KA, Richards JG, Farquhar WB. The effects of anatomical structures on adult forearm and upper arm noninvasive blood pressures. Blood Press Monit. 2007 Feb;12(1):17-22. doi: 10.1097/MBP.0b013e3280858cd0.
- Rose WC, Johnson DA, Spaeth JR, Edwards J, Beris, AN. Computational and experimental investigation of arterial hemodynamics. Proc. 2008 Int. Mech. Eng. Conf. Exp. Boston: ASME, 2008; 1-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 8, 2010
First Submitted That Met QC Criteria
March 15, 2010
First Posted (Estimate)
March 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 7, 2012
Last Update Submitted That Met QC Criteria
November 6, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CCC29150
- NURS175154 (Other Identifier: University of Delaware IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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